UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042909
Receipt number R000045389
Scientific Title Study on improvement of digestive tract environment by green tea catechin
Date of disclosure of the study information 2021/01/06
Last modified on 2024/03/08 21:26:21

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Basic information

Public title

Examination on the effect of green tea catechin on improvement of digestive tract environment

Acronym

Green tea catechin and environment of digestive tract

Scientific Title

Study on improvement of digestive tract environment by green tea catechin

Scientific Title:Acronym

Green tea catechin and environmental improvement in digestive tract

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A catechin intake test will be conducted in healthy subjects to analyze the oral bacterial flora, intestinal bacterial flora, and intestinal / urinary metabolites before and after catechin intake. From this study, we will clarify the effects of catechin on the digestive tract via human oral and intestinal bacteria.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To analyze the change of oral bacteria and fecal bacteria before and after catechin intake by 16S rRNA metagenomic analysis by Illumina Miseq.

Key secondary outcomes

Bile acids and short-chain fatty acids in the stool before and after ingestion, and urinary metabolites are measured before and after catechin intake as metabolites of intestinal bacteria.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

"Catechin" powder (Sanphenon EGCg-OP: manufactured and sold as a supplement by Taiyo Kagaku) is used. The EGCg intake is set to 300 mg / day and the intake period is 4 weeks (28 days).

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1. An adult (regardless of gender) who can obtain a written consent to participate in the research from the person himself / herself.
2. Those who are between the ages of 50 and 70 at the time of obtaining consent (regardless of gender)
3. Those who can comply with the following lifestyle habits during the test period from one week before the start of the test
Do not consume green tea.
Do not consume many foods with high polyphenol content such as chocolate.
Do not take antibiotics.
Do not use mouthwash or mouthwash.
Refrain from taking probiotics (mainly yogurt).
Do not take natto.
Do not smoke
Do not take prebiotics (dietary fiber and oligosaccharide supplements).

Key exclusion criteria

1. Those who are treating diseases that affect the research results (dental and oral diseases, digestive diseases, etc.)
2. Those who have an extremely irregular diet
3. Those who drink a lot of green tea and alcohol on a daily basis
4. Those who habitually engage in strenuous exercise such as marathons
5. Currently, under the guidance of a doctor, those who are or will be doing exercise therapy / diet therapy
6. Serious heart disease [heart failure, myocardial infarction, myocarditis, etc.], liver disease [liver failure symptoms (fulminant hepatitis), liver cirrhosis, liver tumor], renal disease [nephrotic syndrome, renal failure (acute and chronic), urinary poisoning Disease, hydronephrotic syndrome], neurological disease, psychiatric disease, malignant tumor disease, etc., and those who have general condition problems
7. Those who have participated in other clinical trials within one month before obtaining consent or who plan to participate in other clinical trials during the trial period.
8. In addition, those who are judged by the investigator to be inappropriate for the study (the risk to the study subject may increase or sufficient data may not be obtained).

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto Japan

TEL

075-251-5519

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto Japan

TEL

075-251-5519

Homepage URL


Email

ynaito@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Taiyo Kagaku Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Laboratory of Animal Science, Setsunan University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine, Ethnical Review Board

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku, Kyoto Japan

Tel

075-251-5337

Email

rinri@koto.kpu-m.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 01 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

Results

In the subjective physical condition questionnaire, which was the primary endpoint, the number of symptomatic days was statistically significantly lower in the active sencha tea group compared to the placebo hojicha group.

Results date posted

2024 Year 03 Month 08 Day

Results Delayed

Delay expected

Results Delay Reason

Because other analysis details are required.

Date of the first journal publication of results

2024 Year 12 Month 31 Day

Baseline Characteristics

Healthy Japanese men and women aged 50 to under 75

Participant flow

Healthy Japanese men and women aged 50 to under 75 will consume the research food for 4 weeks to verify the effectiveness and safety of the research ingredients on immune function.
Research method: A double-blind parallel group comparative study will be conducted in this study. Forty Japanese research subjects eligible to participate in this study were randomly assigned in a 1:1 ratio to a test food intake group and a placebo food intake group to evaluate the efficacy and safety of the research ingredients on immune function. investigate.

Adverse events


Outcome measures


Plan to share IPD

(1) Primary endpoint: Questionnaire regarding physical condition (2) Secondary endpoints: Blood immune index, immune cell profiling, blood cytokine concentration, IgA (saliva), oral flora, intestinal flora, body temperature.

IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2020 Year 05 Month 13 Day

Date of IRB

2020 Year 05 Month 13 Day

Anticipated trial start date

2020 Year 05 Month 13 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1. Statistical analysis method
Metagenomic analysis is performed in bacterial flora analysis. As a specific analysis method, the next-generation sequencer (NGS) analysis of the V3-V4 region of the 16S rRNA gene was performed on the intestinal flora using the collected feces, and the phylum-genus level of various intestinal flora was performed. The analysis will be performed using a pipeline for NGS data analysis consisting of five bioinformatics programs containing USEARCH (Edgar, 2010), QIIME (Caporaso et al. 2010), PICRUSt (Langille et al. 2013), FishTaco (Manor and Borenstein, 2017), and Phylloseq(McMurdie and Holms, 2013).

2. Cancellation of clinical trials
2-1. Occurrence of adverse events
If the investigator determines that the subject's clinical research continuation is not appropriate due to the occurrence of adverse events, the subject's clinical research will be immediately discontinued. If the clinical study is discontinued, the investigator will evaluate the association with the study food, record it along with the reason for discontinuation, and promptly notify the subject.
2-2. Subject's offer
If the subject's request discontinues participation or continuation of clinical research regardless of whether or not it is related to clinical research, including the person's free will, accidental accident, or illness, the investigator will discontinue the clinical research of that subject. ..
2-3. Not eligible for clinical trials
If it is found that the subject is not eligible for this clinical study after the start of the clinical study, or if it is found that the necessary evaluations, observations, tests, etc. cannot be performed due to the convenience of the subject after the start of the clinical study. Immediately discontinue the subject's clinical study and promptly notify the subject.


Management information

Registered date

2021 Year 01 Month 05 Day

Last modified on

2024 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045389


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name